Over-tube, method of manufacturing over-tube, method of disposing over-tube, and method of treatment in abdominal cavity

ABSTRACT

An over-tube for use in an endoscopic treatment in an abdominal cavity using an endoscope includes an over-tube main body which is inserted from a distal portion thereof via a natural opening in a patient&#39;s body to access the inside of the abdominal cavity from the distal portion through a lumen wall, and an internal cover which is disposed in a passage of the endoscope disposed in an inner cavity of the over-tube main body and which is extractable from a proximal portion of the over-tube main body.

CROSS REFERENCE TO RELATED APPLICATIONS

This is a Continuation Application of PCT Application No.PCT/JP2004/001363, filed Feb. 10, 2004, which was published under PCTArticle 21(2) in Japanese.

This application is based upon and claims the benefit of priority fromprior U.S. provisional Patent Application No. 60/446,447, filed Feb. 11,2003, the entire contents of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an over-tube for use, for example, inan abdominal cavity surgical operation, a method of manufacturing anover-tube, a method of disposing an over-tube, and a method of treatmentin an abdominal cavity.

2. Description of the Related Art

Method of abdominal cavity surgical operations using over-tubes has beendescribed, for example, in U.S. Pat. No. 5,458,181 and U.S. Pat. No.5,297,536. As shown in FIG. 26, in both the methods, an over-tube 300 isinserted into an abdominal cavity from a natural opening 310 in thepatient's body through a lumen wall. For example, an endoscope 320 or atreatment device 330 can be allowed to detachably access the abdominalcavity through the over-tube 300.

BRIEF SUMMARY OF THE INVENTION

One aspect of an over-tube which is used in combination with anendoscope having an elongated insertion section includes:

an over-tube main body having a distal portion on one end of anelongated tube and a proximal portion on the other end thereof and beingcapable of passing the insertion section of the endoscope, the over-tubemain body being inserted from the distal portion thereof into apatient's body through a natural opening to access an abdominal cavitythrough a lumen wall from the distal portion thereof; and

at least one internal cover which has a tubular shape and through whichthe insertion section of the endoscope is inserted in a detachablyinserted state in an inner cavity of the over-tube main body, theinternal cover having a distal portion which is disposed in a protrudedstate further on a front side from the distal portion of the over-tubemain body and which covers an outer peripheral surface of the distalportion of the over-tube main body, and a proximal portion protruded ona hand side from the proximal portion of the over-tube main body, sothat the internal cover is extractible from the proximal portion of theover-tube main body.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING

FIG. 1A is a perspective view showing an appearance of an over-tubeaccording to a first embodiment of the present invention;

FIG. 1B is an exploded perspective view of the over-tube according tothe first embodiment of the present invention;

FIG. 2 is a sectional view showing a hand portion of the over-tubeaccording to the first embodiment of the present invention;

FIG. 3A is a perspective view showing the vicinity of a distal endportion of a tube sheath in a state in which a coil is disposed in awall in the over-tube according to the first embodiment of the presentinvention;

FIG. 3B is a sectional view showing the vicinity of the distal endportion of the tube sheath in a state in which the coil is disposed inthe wall in the over-tube according to the first embodiment of thepresent invention;

FIG. 4A is a sectional view showing the distal end portion of theover-tube sheath showing a first step of preparing the tube sheath in astate in which the coil is disposed in the wall in the over-tubeaccording to the first embodiment of the present invention;

FIG. 4B is a sectional view of the distal end portion of the over-tubesheath showing a second step of preparing the tube sheath in a state inwhich the coil is disposed in the wall in the over-tube according to thefirst embodiment of the present invention;

FIG. 4C is a sectional view of the distal end portion of the over-tubesheath showing a third step of preparing the tube sheath in a state inwhich the coil is disposed in the wall in the over-tube according to thefirst embodiment of the present invention;

FIG. 4D is a sectional view of the distal end portion of the over-tubesheath showing a fourth step of preparing the tube sheath in a state inwhich the coil is disposed in the wall in the over-tube according to thefirst embodiment of the present invention;

FIG. 4E is a sectional view of the distal end portion of the over-tubesheath showing a fifth step of preparing the tube sheath in a state inwhich the coil is disposed in the wall in the over-tube according to thefirst embodiment of the present invention;

FIG. 4F is a sectional view of the distal end portion of the over-tubesheath showing a sixth step of preparing the tube sheath in a state inwhich the coil is disposed in the wall in the over-tube according to thefirst embodiment of the present invention;

FIG. 4G is a sectional view of the distal end portion of the over-tubesheath after the end of the sixth step of preparing the tube sheath in astate in which the coil is disposed in the wall in the over-tubeaccording to the first embodiment of the present invention;

FIG. 5A is a schematic sectional view showing a state in which anelastic member of a tip of an internal cover is released from an engagedstate with respect to an outer peripheral portion of the over-tubesheath in the over-tube according to the first embodiment of the presentinvention;

FIG. 5B is a schematic sectional view showing a state in which theelastic member of the tip of the internal cover is engaged with theouter peripheral portion of the over-tube sheath in the over-tubeaccording to the first embodiment of the present invention;

FIG. 5C is a schematic diagram showing the elastic member of the tip ofthe internal cover in the over-tube according to the first embodiment ofthe present invention;

FIG. 5D is a schematic diagram showing another elastic member of the tipof the internal cover in the over-tube according to the first embodimentof the present invention;

FIG. 5E is a schematic diagram showing a state in which another elasticmember of the tip of the internal cover is modified with respect to FIG.5D in the over-tube according to the first embodiment of the presentinvention;

FIG. 6 is a schematic sectional view of a hand portion in a state inwhich an endoscope is inserted in an over-tube main body in theover-tube according to the first embodiment of the present invention;

FIG. 7 is a schematic perspective view showing a state in which theendoscope is inserted in the over-tube according to the first embodimentof the present invention;

FIG. 8 is a schematic perspective view showing that the internal coveris extracted from the over-tube main body in a state in which the distalend of the over-tube is inserted in a lumen wall according to the firstembodiment of the present invention;

FIG. 9 is a schematic diagram showing that the over-tube and endoscopeare introduced into a target body part in a state in which the endoscopeis introduced in the over-tube main body in the over-tube according tothe first embodiment of the present invention;

FIG. 10A is an outline view showing a state in which a lower esophagusis peeled with a peeling instrument by esophagus cardiac musculiincision;

FIG. 10B is an outline view showing a state in which the esophaguscardiac musculi of the lower esophagus is marked with a markinginstrument by the esophagus cardiac musculi incision;

FIG. 11A is an outline view showing a state in which a marked part isincised with an incision instrument by the esophagus cardiac musculiincision;

FIG. 11B is an outline view showing a state in which the part incised bythe esophagus cardiac musculi incision is stitched with a stitchinginstrument;

FIG. 11C is an outline view showing a stitched state with the stitchinginstrument by the esophagus cardiac musculi incision;

FIG. 12 is an outline view showing that the abdominal cavity is cleanedwith a cleaning water supply/suction instrument via the endoscope in astate in which the over-tube and endoscope are introduced into thetarget part of the body according to the first embodiment of the presentinvention;

FIG. 13 is an outline view showing a state in which a vagus nerve branchis accessed by vagus nerve separation;

FIG. 14A is a schematic diagram showing a state in which a serousmembrane of a stomach is excised with the incision instrument by thevagus nerve separation;

FIG. 14B is a schematic diagram showing a state in which blood vessel,nerve, and fat are peeled with the peeling instrument by the vagus nerveseparation;

FIG. 14C is a schematic diagram showing a state in which the bloodvessel and nerve are ligated with a ligation instrument by the vagusnerve separation;

FIG. 14D is a schematic diagram showing a state in which the bloodvessel and nerve between the ligated parts are separated with aseparation instrument by the vagus nerve separation;

FIG. 15A is an outline view showing a state in which mesoappendix isallowed to dehisce with the peeling instrument by appendix excision;

FIG. 15B is an outline view showing a state in which opposite sides ofthe separated part of appendicular root are ligated with the ligationinstrument by the appendix excision;

FIG. 15C is an outline view showing a state in which the appendicularroot is separated with the separation instrument by the appendixexcision;

FIG. 16A is a schematic perspective view showing a state in which theinside of the tube sheath of the over-tube is formed into double lumenaccording to the first embodiment of the present invention;

FIG. 16B is a schematic perspective view showing a state in which atubular member is attached to the outside of the tube sheath of theover-tube according to the first embodiment of the present invention;

FIG. 17A is a schematic side view showing that the internal cover havingperforations formed in a tip thereof is engaged with the outerperipheral surface of the tube sheath in the over-tube according to thefirst embodiment of the present invention;

FIG. 17B is a schematic side view showing that the tip of the internalcover whose perforations in the tip are cut is engaged with the outerperipheral surface of the tube sheath in the over-tube according to thefirst embodiment of the present invention;

FIG. 18 is a schematic side view showing a state in which the tip of theinternal cover is engaged with the outer peripheral surface of the tubesheath by an adhesive tape on the distal end in the over-tube accordingto the first embodiment of the present invention;

FIG. 19A is an exploded perspective view of the over-tube according to asecond embodiment of the present invention;

FIG. 19B is a perspective view showing an outline of the over-tubeaccording to the second embodiment of the present invention;

FIG. 20A is an exploded perspective view of the over-tube according to athird embodiment of the present invention;

FIG. 20B is a perspective view showing an outline of the over-tubeaccording to the third embodiment of the present invention;

FIG. 21 is a schematic sectional view of a distal end portion of theover-tube according to a fourth embodiment of the present invention;

FIG. 22A is a perspective view showing an outline of the over-tubeaccording to a fifth embodiment of the present invention;

FIG. 22B is an exploded perspective view of the over-tube according tothe fifth embodiment of the present invention;

FIG. 23A is a schematic diagram showing a sheet member in the over-tubeaccording to a sixth embodiment of the present invention;

FIG. 23B is a schematic diagram showing a rounded state of the sheetmember in the over-tube according to the sixth embodiment of the presentinvention;

FIG. 23C is an exploded perspective view of the over-tube according tothe sixth embodiment of the present invention;

FIG. 23D is a perspective view showing an outline of the over-tubeaccording to the sixth embodiment of the present invention;

FIG. 24 is a perspective view showing an over-tube provided with abending mechanism according to a seventh embodiment of the presentinvention;

FIG. 25 is a schematic perspective view showing a state in which theendoscope and an introducer are inserted into an inner cavity of theover-tube according to an eighth embodiment of the present invention;and

FIG. 26 is a schematic diagram showing an prior art.

DETAILED DESCRIPTION OF THE INVENTION

Best modes (hereinafter referred to as the embodiments) for carrying outthe present invention will be described hereinafter with reference tothe drawings.

First, an over-tube 10 according to a first embodiment will be describedwith reference to FIGS. 1A to 15C.

The over-tube 10 shown in FIGS. 1A and 1B is used for allowing, forexample, an endoscope or the like to access an abdominal cavity from anatural opening (mouth or anus) in the patient's body through a lumenwall.

As shown in FIG. 1A, the over-tube 10 includes an elongated over-tubemain body 12. The main body 12 includes an elongated over-tube sheath14, and an over-tube hand portion 16 disposed on a proximal end portionof the sheath 14.

The over-tube sheath 14 includes one lumen (passage) for passing atleast an endoscope 90 described later. A section of the sheath 14 has,for example, a schematically circular shape (round type). A distal endportion and proximal end portion of the sheath 14 communicate with eachother through an inner cavity.

In a material of the tube sheath 14, an elastic material is usedincluding polymer resins having stretching properties, such as vinylchloride, vinyl chloride-vinyl acetate copolymer, polyurethane, andfluorine plastic, natural or synthetic rubber latex, synthetic rubberssuch as silicon rubber, isoprene rubber, and neoprene rubber, orelastomers containing polystyrene, polyester, polyether, and polyolefinas main components.

A length of the over-tube sheath 14 is set to such an extent that thesheath 14 is inserted via the natural opening in the human body and iscapable of reaching a target part in the body. The length of the sheath14 is, for example, 300 mm to 5000 mm, especially preferably 500 mm to1000 mm.

The outer diameter of the sheath 14 is set to such an extent that thesheath 14 can be inserted from the natural opening in the human body.The outer diameter of the sheath 14 is, for example, 5 mm to 32 mm,especially preferably 5 mm to 27 mm.

The inner diameter of the sheath 14 is set to such an extent that aninsertion section of the endoscope 90 or a treatment device can beinserted. The inner diameter of the sheath 14 is, for example, 3 mm to30 mm, especially preferably 3 mm to 25 mm.

An annular groove (detachable portion) 19 is formed in the outerperipheral surface in the vicinity of the distal end portion of thesheath 14 in a peripheral direction. A tip of an internal cover 60described later is engaged with and fixed to the annular groove 19. Itis to be noted that convex portions may be formed at predetermineddistance intervals on the outer peripheral surface in such a manner asto engage with an elastic member 62 described later, instead of theannular groove 19. When the elastic member 62 is formed of a materialthat does not easily slip with respect to the outer peripheral surfaceof the sheath 14, the annular groove 19 does not have to be disposed,and the outer peripheral surface may be formed to be flat.

A suction port 18 formed of a tubular member is protruded on the outerperipheral surface of the over-tube hand portion 16. By the suction port18, the inner cavity of the sheath 14 communicates with an outer portionof the hand portion 16. With respect to the suction port 18, forexample, a suction tube (not shown) connected to a suction machine (notshown) is connected, or a cap (not shown) is attached in order tomaintain air tightness in the over-tube main body 12.

As shown in FIG. 2, the hand portion 16 includes a hard pipe-shapedmember 20 formed, for example, of a resin material. On a distal end sideof the pipe-shaped member 20, a cylindrical first small-diameter portion20 a formed into a diameter smaller than that of the proximal portion isdisposed concentrically and integrally with the pipe-shaped member 20.Further inside the first small-diameter portion 20 a, a cylindricalsecond small-diameter portion 20 b is concentrically disposed. Theproximal end portion of the sheath 14 is pressed in and held between thefirst small-diameter portion 20 a and the second small-diameter portion20 b. In this manner, the over-tube sheath 14 is connected to the tubehand portion 16. The proximal end portion of the sheath 14 and the handportion 16 (pipe-shaped member 20) are held between the first and secondsmall-diameter portions 20 a, 20 b, and fixed in an auxiliary manner,for example, by ultrasonic fusion bonding, thermal fusion bonding,bonding by solvent adhesive, screwing and the like.

On the outer peripheral surface from the first small-diameter portion 20a to the vicinity of the proximal end portion of the sheath 14, acylindrical cover member 20 c which covers the first small-diameterportion 20 a and the proximal end portion of the sheath 14 on an outerperipheral side is disposed. The cover member 20 c has a function ofpreventing the sheath 14 from being broken, while a connected state ofthe sheath 14 to the hand portion 16 is strengthened.

In the inner portion (inner cavity) of the pipe-shaped member 20, avalve mechanism (isolation mechanism) is disposed on a proximal end sidefrom a position in which the suction port 18 is protruded on order toprevent sucked or fed air from being released to the outside from theinner portion of the over-tube main body 12. The valve mechanismincludes cylindrical or annular first to third valve guards 22, 24, 26arranged parallel to each other along an axial direction of the mainbody 12. Outer peripheral portions of valves 28, 28 are held between thefirst and second valve guards 22, 24 and between the second and thirdvalve guards 24, 26. That is, the outer peripheral portions of thevalves 28, 28 are held by holding portions 30, 30 formed between facingend portions of the first and second valve guards 22, 24 and betweenfacing end portions of the second and third valve guards 24, 26.

The outer peripheral surfaces of the first to third valve guards 22, 24,26 are preferably formed in such a manner as to adhere to an inner wallof the pipe-shaped member 20. On the other hand, a minimuminner-diameter portion of an inner peripheral surface of each of thevalve guards 22, 24, 26 has a diameter smaller than that of each of theholding portions 30, 30 which hold the respective valves 28, 28.Therefore, these holding portions 30, 30 of the valves 28, 28 compriserelief portions 32, 32 gently tilted (dimension change) toward theabove-described minimum inner-diameter portion. These relief portions32, 32 are constituted to secure deformation regions where the valves28, 28 deform. The diameter of the minimum inner-diameter portion ispreferably set to have a dimension which is equal to the inner diameterof the over-tube sheath 14 or which is larger by ten percent.

The valves 28, 28 are formed of elastic members such as rubbermaterials, have flexibility, and are formed, for example, into discshapes, and through-holes are formed in middle portions of the valves28, 28. The diameter of each through-hole of the valves 28, 28 issmaller than an outer diameter of the insertion section of the endoscope90. Therefore, for example, when the endoscope 90 is inserted into thepipe-shaped member 20, the valves 28, 28 adhere to the outer peripheralsurface of the insertion section of the endoscope 90, and airtightnessbetween interior and exterior of the body is maintained.

The over-tube main body 12 is formed in this manner.

Next, a structure of the over-tube sheath 14 will be described. As shownin FIGS. 3A and 3B, a reinforcing coil 40 is concentrically disposedbetween the inner wall and outer wall (in the wall) of the sheath 14.The sheath 14 obtains desired softness and strength by this reinforcingcoil 40. This reinforcing coil 40 is formed, for example, of a SUSmaterial, and has a desired spring property. An element wire diameter ofthe reinforcing coil 40 is preferably set, for example, to about 0.5 mm.In a case where a thickness of the sheath 14 is about 1 mm, when theelement wire diameter is less than 0.4 mm, resistance to buckling of thesheath 14 is poor. When the element wire diameter exceeds 0.5 mm, theflexibility of the sheath 14 is uniformly poor.

As shown in FIG. 3A, a tip of the reinforcing coil 40 is bent back intoa state in which any peak portion does not exist, and bonded to a bondportion 42 in an appropriate position of a part of the reinforcing coil40 itself by welding. Therefore, the distal end portion of the coil 40is prevented from being exposed to the inside/outside of the tube sheath14 while the tip itself of the reinforcing coil 40 breaks through theinner wall or outer wall of the tube sheath 14.

As shown in FIG. 3B, a portion shown by code L in which the reinforcingcoil 40 does not exist is disposed, for example, by about 20 mm to 80 mmin the tip of the over-tube sheath 14. The distal end portion of thesheath 14 is more flexible than a portion provided with the coil 40.Therefore, an insertion property with respect to the internal of thebody can be enhanced as compared with a case where the portion providedwith the coil 40 is disposed on the distal end portion of the sheath 14.

A method of manufacturing the sheath 14 in which this reinforcing coil40 is buried between the inner wall and the outer wall of the over-tubesheath 14, that is, in the wall will be described with reference toFIGS. 4A to 4G.

As shown in FIG. 4A, the reinforcing coils 40, and a tube 44 formed of athermoplastic resin and having an inner diameter smaller than an outerdiameter of the reinforcing coil 40 are prepared (first step). Forexample, polyurethane or the like is used in the tube 44 formed of thethermoplastic resin.

As shown in FIG. 4B, the diameter of the reinforcing coil 40 is reduced,and the coil 40 is inserted into the lumen of the tube 44. A cored bar46 is inserted inside the lumen of the tube 44, and inside thereinforcing coil 40 (second step). The cored bar 46 is set at anouter-diameter dimension equal to the inner-diameter dimension at a timewhen the cored bar 46 is formed as the over-tube sheath 14. The coredbar 46 may have a tubular shape having a lumen inside. The cored bar 46may have an inner lumen, and a micro-hole extending through the coredbar 46 on the side of the outer peripheral surface from the lumen.

As shown in FIG. 4C, the tube 44 in a state of the second step is coatedwith a heat-shrinkable tube 48 (third step). The heat-shrinkable tube 48has a length substantially equal to that of the tube 44, or a length alittle larger than that of the tube 44, and is thermally shrunk inwardsin a diametric direction at a temperature exceeding a melting point ofthe tube 44.

In a state in which the third step ends, a heating step (fourth step) isperformed. The heat-shrinkable tube 48 is heated to a temperature atwhich the tube is shrunk inwards in the diametric direction. In thiscase, when the cored bar 46 is tubular and has micro-holes, a step ofdecompressing a tubular inner portion of the cored bar 46 may be added.

In the fourth step, the tube 44 is heated at a temperature higher thanthe melting point of the tube 44. Therefore, the tube 44 itself ismolten. The heat-shrinkable tube 48 disposed on the outer peripheralside of the tube 44 is shrunk inwards in the diametric direction. Thetube 44 is pressed inwards following the shrinking of theheat-shrinkable tube 48, and both the inner diameter and the outerdiameter of the tube 44 are shrunk. At the time of the melting of thetube 44, a force to urge the reinforcing coil 40 in such a manner as toreduce the diameter is not transmitted to the reinforcing coil 40.Therefore, the reinforcing coil 40 swells outwards in the diametricdirection, and is buried in the wall of the molten tube 44. On the otherhand, the diameter of the heat-shrinkable tube 48 is reduced, and theouter diameter of the cored bar 46 is held in an unchanged state.Therefore, the reinforcing coil 40 is held inwards in the diametricdirection in a reduced-diameter state against an urging force by theheat-shrinkable tube 48. Therefore, the heat-shrinkable tube 48 and tube44 are cooled. Then, as shown in FIG. 4D, the heat-shrinkable tube 48and the tube 44 are integrated to form the over-tube sheath 14 in astate in which the reinforcing coils 40 are buried in the tube 44. It isto be noted that when the cored bar 46 provided with the micro-holes inthe fourth step is used, and the inside of the sheath 14 isdecompressed, a movement in which the sheath 14 is reduced (formed) ispromoted. Therefore, the sheath 14 can be prepared in a short time.

Thereafter, as shown in FIG. 4E, the cored bar 46 is extracted from thesheath 14 (fifth step).

Subsequently, a sixth step is performed. As shown in FIG. 4F, a die 50is used in which concave portions 52 having R shapes (semisphericalsectional shapes) are formed into annular shapes. The distal end portionof the sheath 14 is heated and attached onto the concave portions 52 ofthe die 50. As shown in FIG. 4G, the tip of the sheath 14 is formed intoa rounded state.

By the above-described first to sixth steps, unlike an extrusion step ora dipping step, the sheath 14 containing the reinforcing coils 40 can beeasily manufactured without preparing an exclusive-use manufacturingapparatus.

Since a large pressure is not loaded onto the sheath 14 as in theextrusion step, the reinforcing coils 40 are prevented from beingirregularly shifted in the wall of the sheath 14, and the sheath 14whose quality has been stabilized can be manufactured. Since a resindoes not have to be dissolved in a solvent as in the dipping step, it isnot necessary to study solubility of the resin with respect to thesolvent, and the sheath can be easily manufactured.

As shown in FIGS. 1A and 1B, the internal cover (cylindrical member) 60is detachably attached from the proximal end portion of the tube mainbody 12 to the distal end portion thereof in the inner cavity of theover-tube main body 12 formed in this manner. The internal cover 60 isformed of polymer resin materials such as vinyl chloride, polyethylene,and polypropylene, and formed into a soft film which is not easilybroken and which has permeability to a gas such as an ethylene oxide gasand/or resistance to γ-rays. The internal cover 60 preferably hasantibacterial specifications.

As shown in FIG. 5A, an annular elastic member 62 is disposed on thedistal end portion (distal end portion) of the internal cover 60. Thevicinity of the distal end portion of the internal cover 60 protrudesoutwards from the distal end portion of the over-tube sheath 14. Asshown in FIGS. 1A and 5B, a portion (distal end portion) protruding withrespect to the distal end portion of the over-tube sheath 14 is foldedback outwards. As shown in FIG. 5B, the elastic member 62 is engagedwith the annular groove 19 in the outer peripheral surface of theover-tube sheath 14.

In this case, as shown in FIG. 1A, the proximal end portion (proximalportion) of the internal cover 60 protrudes further on a hand side fromthe proximal end portion of the hand portion 16 of the tube main body12. When the internal cover 60 is pulled on a hand side, the engagementof the elastic member 62 in the annular groove 19 is released in theouter peripheral surface in the vicinity of the distal end portion ofthe tube sheath 14. Therefore, the internal cover 60 is recovered withrespect to the over-tube main body 12.

It is to be noted that as the annular elastic member 62, as shown inFIG. 5C, a ring having a shrinking property, for example, a rubbermaterial is used. A C-shaped elastic member 66 may be used such as ametal or a resin which is elastically deformable, for example, between ashrunk state shown in FIG. 5D and an expanded state shown in FIG. 5E andwhich has a spring property.

The over-tube 10 is formed in this manner.

Next, a function of the over-tube 10 having this constitution will bedescribed with reference to FIGS. 6 to 15C.

First, the internal cover 60 shown in FIG. 1B is inserted into the innercavity of the over-tube main body 12. The tip of the internal cover 60is folded back outwards at the tip of the over-tube sheath 14. Theelastic member 62 on the tip of the internal cover 60 is engaged withthe annular groove 19 in the outer peripheral surface of the sheath 14.Therefore, as shown in FIG. 1A, the over-tube 10 is prepared. In thiscase, the proximal end of the internal cover 60 is protruded from theover-tube hand portion 16 on the hand side.

The endoscope 90 and a treatment device (not shown) are passed throughthe over-tube 10 from a proximal end portion side toward a distal endportion side. That is, as shown in FIG. 6, the endoscope 90 and thetreatment device are inserted through the inner cavity of the internalcover 60. When the endoscope 90 or the treatment device is inserted intothe over-tube main body 12 in this manner, the endoscope 90 or thetreatment device is deflected inside the hand portion 16. The minimuminner-diameter portions of the first to third valve guards 22, 24, 26are formed into dimensions each of which is substantially equal to theinner diameter of the sheath 14, and therefore the endoscope 90 is urgedby the valves 28, 28 in such a manner that the endoscope is centered onthe side of the middle of the hand portion 16. When the endoscope 90 orthe treatment device is inserted, the valves 28, 28 are gently deflectedalong tilts of the relief portions 32, 32. In this case, the hand sideof the hand portion 16 and the distal end portion side of the handportion 16 are brought into mutually airtight states by the valves 28,28.

As shown in FIG. 7, the over-tube 10 provided with the endoscope 90 inthis manner is inserted into a lumen wall 100 from the natural openingin the patient's body. The lumen wall 100 is opened using the endoscope90 and the treatment device.

After the distal end portion of the sheath 14 of the over-tube main body12 is engaged with and fixed to the opening in the lumen wall 100, theendoscope 90 and the treatment device are pulled and extracted withrespect to the proximal end portion of the main body 12 on the handside. In this state, the internal cover 60 in the main body 12 is pulledwith respect to the proximal end portion of the main body 12 on the handside.

As shown in FIG. 5A, an engaged state of the elastic member 62 of thetip of the internal cover 60 with the annular groove 19 in the vicinityof the distal end portion of the main body 12 (sheath 14) is released.The elastic member 62 of the tip of the internal cover 60 is drawn intothe inner cavity of the main body 12 between the lumen wall 100 and thevicinity of distal end portion of the main body 12 (sheath 14). That is,by the urging force at a time when the engaged state of the elasticmember 62 of the internal cover 60 with the annular groove 19 in theouter peripheral surface of the main body 12 is released, the main body12 and the lumen wall 100 are elastically deformed, and the elasticmember passes between the both. Therefore, while the elastic member 62of the internal cover 60 returns to a straight state from thefolded-back state, the distal end portion of the main body 12 is drawninto the inner cavity.

As shown in FIG. 8, the internal cover 60 is extracted through the innercavity of the main body 12. For example, deposits such as mucus/contentsin the patient's lumen are attached to the inner peripheral surface ofthe extracted internal cover 60. Therefore, when the internal cover 60is extracted from the main body 12, the deposits are removed. The outerwall of the internal cover 60 is brought into contact only with theinner wall of the sheath 14. Therefore, the inner cavity of theover-tube main body 12 is held in a substantially sterile state.

After extracting the internal cover 60 in this manner, the sterilizednew endoscope 90 and treatment device are inserted into the abdominalcavity via the inner cavity of the over-tube main body 12 to perform anendoscopic treatment as shown in FIG. 9.

The endoscopic treatment in the abdominal cavity via the over-tube 10will be described hereinafter with reference to FIGS. 10A to 15C.

First, esophagus cardiac musculi incision will be described.

As described above, the over-tube 10 having the endoscope 90 and atreatment device for an opening, which have been inserted in the innercavity of the tube 10, is inserted into the stomach from patient's mouththrough the esophagus. The stomach is opened on a stomach body frontwall side with the treatment device for the opening. The over-tube 10 isengaged with and fixed to the opening (not shown). Thereafter, theendoscope 90 and the treatment device for the opening are extracted fromthe inner cavity of the over-tube main body 12. Subsequently, theinternal cover 60 is extracted. A sterilized new endoscope 90, differentfrom the extracted endoscope, is inserted into the abdominal cavitythrough the inner cavity of the over-tube main body 12.

The tip of the endoscope 90 is guided into a lower esophagus 110 in theabdominal cavity. As a method of guiding the endoscope 90, the followingsystem is used. For example, a method of inserting a light emittinginstrument into an organ in the abdominal cavity to guide the endoscopeby light, a method of two-dimensionally guiding the endoscope by afluoroscope, a method of three-dimensionally guiding the endoscope by anendoscope insertion shape observation apparatus; and the like are used.

As shown in FIG. 10A, the lower esophagus 110 is peeled and exposed by apeeling instrument 112 passed through a channel (not shown) of theendoscope 90. As the peeling instrument 112, multiple degrees of freedomforceps, rod-shaped peeling forceps,needle-shaped/hook-shaped/spatula-shaped/clamp forceps type/peelingforceps type/scissors forceps type/IT knife/snare type high-frequencyincision instruments, needle-shaped/hook-shaped/spatula-shaped/clampforceps type ultrasonic solidifying incision instruments, lasertreatment devices and the like are used.

As shown in FIG. 10B, an incised part of a esophagus cardiac musculi ofthe lower esophagus 110 is marked by a marking instrument 114. As themarking instrument 114, a tattooing by local-injection needle, clip,electric heating instruments such as a high-frequency incisioninstrument and a heat knife and the like are used.

As shown in FIG. 11A, a cardiac musculi layer of a marked part isincised by an incision instrument 116. As the incision instrument 116,scissorsforceps/bow-shaped/needle-shaped/hook-shaped/spatula-shaped/clampforceps type/peeling forceps type/scissors forceps type/IT knifehigh-frequency incision instruments,needle-shaped/hook-shaped/spatula-shaped/clamp forceps type ultrasonicsolidifying incision instrument, laser treatment device, ahigh-frequency incision cap, Malecott knife and the like are used. It isto be noted that the incision instrument 116 is preferably provided witha guide mechanism for protecting nerve/blood vessel/tissue and the like.

As shown in FIG. 11B, knotting stitching is performed to knot-bond anesophagus side musculi incised edge 110 a and a stomach serous membrane110 b outside a stomach side incised edge, incised with the incisioninstrument 116, by a stitching instrument 120 (see FIG. 11C). As thestitching instrument 120, a thread stitching unit, clip, stapler, T-barstitching unit and the like are used.

After ending this treatment, as shown in FIG. 12, the interior of theabdominal cavity is cleaned with a warm physiological salt solution by acleaning water supply/suction instrument 122. The cleaning water may besupplied from a cleaning tube (not shown), or supplied from theendoscope 90 or the inner cavity of the over-tube main body 12. Thecleaning water may be sucked by a suction tube (not shown), or sucked bythe endoscope 90 or the inner cavity of the main body 12.

After extracting the endoscope 90 from the inner cavity of the over-tubemain body 12, the over-tube 10 is extracted. Subsequently, the stomachopening is closed.

Next, vagus nerve separation will be described.

In the same manner as in the esophagus cardiac musculi incision, theover-tube 10 is fixed to the opening, and the sterilized endoscope 90 isinserted into the abdominal cavity through the inner cavity of theover-tube main body 12.

As shown in FIG. 13, the tip of the endoscope 90 is guided into a vagusnerve branch 130 on the side of a mouth of an antropyloric branch in theabove-described guiding method. Moreover, as shown in FIG. 14A, astomach serous membrane 132 is excised by the above-described incisioninstrument 116 passed through a channel (not shown) of the endoscope 90.

As shown in FIG. 14B, a blood vessel 134 and a nerve 136 are peeled offfrom a fat 138 by the above-described peeling instrument 112.

As shown in FIG. 14C, opposite sides of separated parts of the bloodvessel 134 and nerve 136 are ligated by a ligation instrument 140 toform ligated portions 142 a, 142 b. As the ligation instrument 140, athread stitching unit, clip, snare and the like are used.

As shown in FIG. 14D, the blood vessel 134 and nerve 136 between theligated portions 142 a, 142 b are separated by a separation instrument146. As the separation instrument 146, scissors forceps,bow-shaped/needle-shaped/hook-shaped/spatula-shaped/clamp forcepstype/peeling forceps type/scissors forceps type/snare typehigh-frequency incision instruments,needle-shaped/hook-shaped/spatula-shaped/clamp forceps type ultrasonicsolidifying incision instrument, laser treatment device and the like areused.

At this time, in the case of bleeding, blood clots/stops by a hemostaticinstrument (not shown). As the hemostatic instrument, a clip, snare,thread stitching unit, high-frequency clamp forceps, heat probe,ultrasonic solidifying incision device, high-frequency solidifier, argonplasma solidifying device, laser treatment device and the like are used.

Thereafter, the endoscope 90 is guided to a stomach body upper surfacerear part. A rear stem of a vagus nerve is exposed using the peelinginstrument 112. In this case, other nerves/blood vessels are protectedbeforehand using a blood vessel/nerve protection instrument. As theprotection instrument, a protective tube, pressure discharge by balloon,traction by thread and the like are used. The rear stem of the bloodvessel/vagus nerve is ligated, and thereafter separated.

As shown in FIG. 12, the interior of the abdominal cavity is cleanedwith the warm physiological salt solution by the cleaning watersupply/suction instrument 122. Moreover, after extracting the endoscope90 from the inner cavity of the over-tube main body 12, the over-tube 10is extracted. Subsequently, the stomach wall opening is closed.

Next, appendix excision will be described.

In the same manner as in the esophagus cardiac musculi incision, theover-tube 10 is fixed to the opening, and the sterilized endoscope 90 isinserted into the abdominal cavity through the inner cavity of theover-tube main body 12.

The tip of the endoscope 90 is guided into an appendix part in theabove-described guiding method. Moreover, as shown in FIG. 15A, amesoappendix 152 of an appendix 150 is divided by the above-describedpeeling instrument 112 passed through the channel (not shown) of theendoscope 90. An appendix artery/vein is separated by theabove-described separation instrument 146.

As shown in FIG. 15B, opposite sides of a separated part of a root ofthe appendix 150 are ligated by the above-described ligation instrument(stitching instrument) 120.

As shown in FIG. 15C, the root of the appendix 150 is separated by theabove-described separation instrument 146. At this time, the cutappendix 150 is clamped and recovered by a clamping instrument 154. Asthe clamping instrument 154, clamp forceps, suction cap and the like areused.

The cut appendix 150 is recovered to the exterior of the body by arecovery instrument (not shown). As the recovery instrument, clampforceps, multi-leg type clamp forceps, basket, suction and the like areused.

As shown in FIG. 12, the interior of the abdominal cavity is cleanedwith the warm physiological salt solution by the cleaning watersupply/suction instrument 122. After extracting the endoscope 90 fromthe inner cavity of the over-tube main body 12, the over-tube 10 isextracted. Subsequently, the stomach wall opening is closed.

Besides the above-described operations, other operations, localinjection or chemical scattering with respect to the tissue in theabdominal cavity, biopsy or cytodiagnosis, image diagnosis of a localpart by an ultrasonic searcher and the like can be performed.

As described above, according to the embodiment, the following effectsare obtained.

In the over-tube hand portion 16, by functions of the minimuminner-diameter portions of the first to third valve guards 22, 24, 26and the valves 28, 28, the endoscope 90 inserted in the inner cavity iscentered. Inner holes (through-holes) of the valves 28, 28 are broughtinto close contact with the outer periphery of the endoscope 90, andhigh airtightness can be secured. Since the relief portions 32, 32 areformed in the first to third valve guards 22, 24, 26, the valves 28, 28are freely deformed even at the time of the insertion of the endoscope90, and a resistance to a large load is maintained. Accordingly, a largeload can be prevented from being applied. Then, in the valve mechanism,an insertion property of the endoscope 90 can be kept high, anddurability of the valve mechanism itself can be secured.

FIG. 16A shows a first modification of the over-tube main body 12. Inthe modification, the over-tube sheath 14 is provided with a channel(tube sheath, lumen) 170 a into which a treatment device can be insertedseparately from the inner cavity into which, for example, the endoscope90 is inserted. The channel 170 a is attached to (formed in) the insideof the over-tube sheath 14. For example, the channel 170 a may be formedintegrally with the over-tube sheath 14.

The channel 170 a is formed, for example, of a polymer resin material,and is formed as a tube sheath having a round section. The channel 170 ahas at least one lumen (passage) for passing the treatment device.

A length of the channel 170 a is set to such an extent that the tubesheath 170 a can be inserted into the body together with the over-tubesheath 14. The length is, for example, 300 mm to 5000 mm, especiallypreferably 500 mm to 1000 mm. The inner diameter of the channel 170 a isset to such an extent that the clamp forceps pass. The diameter is, forexample, 1 mm to 20 mm, especially preferably 2 mm to 10 mm.

FIG. 16B shows a second modification of the over-tube main body 12. Inthis modification, the over-tube sheath 14 is provided with an externaltube (channel, lumen) 170 b into which the treatment device can beinserted, for example, in the same axial direction separately from theinner cavity in which, for example, the endoscope 90 is inserted. Theexternal tube 170 b is attached to the outer side of the over-tubesheath 14 in an external state. The external tube 170 b may be fixed tothe over-tube sheath 14 by pressing-in, bonding (e.g., ultrasonic fusionbonding, thermal fusion bonding, solvent adhesive) and the like. It isto be noted that the length and the inner diameter of the external tube170 b are equal to those of the channel 170 a of the first modificationof the over-tube main body 12.

FIGS. 17A and 17B show a first modification of the internal cover 60. Inthis modification, as shown in FIG. 17A, a structure which can be easilycut, such as a perforation (cut portion) 180, is disposed in theperipheral direction in the vicinity of the tip of the internal cover60. It is to be noted that the tip of the internal cover 60 is engagedwith the annular groove 19, for example, by the elastic member 62. Whenthe internal cover 60 is pulled from the hand side of the over-tube mainbody 12, as shown in FIG. 17B, the internal cover 60 on the hand sidefrom the perforation 180 is cut via the perforation 180 and recovered.

FIG. 18 shows a second modification of the internal cover 60. In themodification, the tip of the internal cover 60 includes, for example, anadhesive tape (detachable portion) 182 which is a detachable portion(adhesive means) on the outer peripheral surface (annular groove 19) inthe vicinity of the distal end portion of the over-tube sheath 14. Whenthe internal cover 60 is pulled on the hand side, the adhesive tape 182peels from the outer peripheral portion of the over-tube sheath 14, andthe internal cover 60 is recovered. In this case, the annular groove 19does not have to be formed by a degree of adhesion of the detachableportion.

Next, a second embodiment will be described with reference to FIGS. 19Aand 19B. Since the embodiment is a modification of the first embodiment,the same members as those described in the first embodiment are denotedwith the same reference numerals, and detailed description thereof isomitted. This also applies to the following third to eighth embodiments.

As shown in FIG. 19A, in an over-tube 10 according to this embodiment, alength of an internal cover 60 is formed into a length about twice thatof an over-tube sheath 14.

In this case, substantially the whole periphery of the outer peripheralsurface of the sheath 14 can be covered in a state in which the proximalend portion of the internal cover 60 is protruded on the hand side ofthe hand portion 16.

It is to be noted that the elastic member 62 (see FIG. 5B) on the tip ofthe internal cover 60 or the annular groove 19 in the outer peripheralsurface of the sheath 14 may be omitted.

The over-tube 10 in this state has a function similar to that describedabove in the first embodiment.

Next, a third embodiment will be described with reference to FIGS. 20Aand 20B.

An over-tube 10 according to the embodiment is different in a structureof an internal cover 60.

As shown in FIG. 20A, the internal cover 60 integrally includes a tubemember (shield tube) 60 a inserted through an over-tube main body 12,and a tubular film-like member 60 b protruded from the tip of the tubemember 60 a.

The internal cover 60 is inserted toward a base end from a tip of theover-tube main body 12. As shown in FIG. 20B, the film-like member 60 bis folded back to cover the outer periphery of the tip of an over-tubesheath 14.

The over-tube 10 in this state has a function similar to that describedabove in the first embodiment.

Next, a fourth embodiment will be described with reference to FIG. 21.

As shown in FIG. 21, an annular groove 19 a is formed in an innerperipheral surface of a tip of an over-tube sheath 14. A tube member(cylindrical member) 60 a is disposed in an over-tube main body 12.Since an O-ring (sealing member) 72 is disposed in the annular groove 19a, the outer peripheral surface of the tube member 60 is held into anairtight state on the hand side from the O-ring 72.

The over-tube 10 in this state has a function similar to that describedabove in the first embodiment.

Next, a fifth embodiment will be described with reference to FIGS. 22Aand 22B.

As shown in FIGS. 22A and 22B, a plurality of internal covers 60 aredisposed inside an over-tube main body 12.

An over-tube 10 in this state has a function similar to that describedabove in the first embodiment.

According to the over-tube 10 of this embodiment, even when an endoscope90 or a treatment device is replaced many times, the internal covers 60are removed one by one, treatment can be performed in a state in which asterile state is constantly maintained.

It is to be noted that the internal cover 60 is not limited to a filmconfiguration, and a tubular configuration may be used.

Next, a sixth embodiment will be described with reference to FIGS. 23Ato 23D.

As shown in FIG. 23A, in an internal cover 60, a sheet-like member 60 cis used instead of a film-like member.

As shown in FIG. 23B, this sheet-like member 60 c is rounded, insertedinto an over-tube main body 12, and used.

As shown in FIG. 23C, the sheet-like member 60 c in a rounded state isinserted toward a distal end portion from a proximal end portion of theover-tube main body 12.

An over-tube 10 formed as shown in FIG. 23D for use has a functionsimilar to that described above in the first embodiment.

Next, a seventh embodiment will be described with reference to FIG. 24.

As shown in FIG. 24, an over-tube main body 12 of an over-tube 10according to the embodiment includes a bending mechanism. An over-tubehand portion 16 of the main body 12 is provided with a knob 190 forbending (bending operation portion) together with a valve mechanism (notshown). In the main body 12, for example, one to four wires 191 aredisposed. The distal end portion of each wire 191 is connected to thedistal end portion of an over-tube sheath 14. The proximal end portionof the wire 191 is extended on a hand portion 16 side. The knob 190 forbending is connected to a sprocket for driving, which tightens orloosens the wire 191.

It is to be noted that the over-tube main body 12 further includes achannel. An opening 192 of the channel is formed in the distal endportion of the over-tube sheath 14. The hand portion 16 includes aforceps plug 193 of the channel.

Next, a function of the over-tube 10 having this constitution will bedescribed.

An internal cover 60 is disposed in an inner cavity of the over-tube 10.An endoscope 90 and a treatment device are inserted into the innercavity of the internal cover 60 beforehand. When the over-tube 10 inthis state is inserted to a lumen wall 100 (see FIGS. 7 and 8) through anatural opening in the patient's body, a predetermined part is accessedusing the bending mechanism of the over-tube 10.

The over-tube 10 in a state in which the endoscope 90 and the treatmentdevice are inserted into the inner cavity is inserted from the naturalopening in the human body, and the knob 190 for bending is operated. Bythe operation of the knob 190 for bending, the sprocket for driving isdriven to tighten or loosen the wire 191, and the over-tube sheath 14 isbent in a desired direction.

The over-tube main body 12 is bent in this manner to thereby bend theendoscope 90 and treatment device following the main body 12, while thedistal end portion of the over-tube sheath 14 is introduced into adesired position (lumen wall 100 shown in FIGS. 7 and 8).

By the use of a channel in the over-tube main body 12, for example, airfeeding/water feeding, suction and the like are performed.

Since other functions are similar to those of the first embodiment,description thereof is omitted.

As described above, according to this embodiment, the following effectis obtained. It is to be noted that description of the effect describedin the first embodiment is omitted.

Since the bending mechanism for bending the over-tube 10 is disposed,the over-tube 10 is easily allowed to access a target part in the lumenwall 100.

Even in a state in which an endoscope and the like are not disposedinside the over-tube 10, the air feeding/water feeding, suction and thelike can be performed.

Next, an eighth embodiment will be described with reference to FIG. 25.

As shown in FIG. 25, an introducer 194 is inserted into an over-tubemain body 12. An endoscope 90 and a treatment device are inserted in aninner cavity of this introducer 194.

The introducer 194 includes a tubular introducer sheath 196, and anintroducer hand portion 198 disposed on a base end of the introducersheath 196. The introducer sheath 196 is formed, for example, of apolymer resin material, and a section is formed as a round tube. Theintroducer sheath 196 includes one lumen (passage) for passing at leastthe endoscope 90.

A length of the introducer sheath 196 is set to such an extent that thesheath 196 can be inserted from the natural opening in the human body toreach the target part in the body. The length is, for example, 300 mm to5000 mm, especially preferably about 500 mm to 1000 mm. The outerdiameter of the introducer sheath 196 is set to such an extent that thesheath 196 can be inserted from the natural opening in the human body.The diameter is, for example, 5 mm to 30 mm, especially preferably about5 mm to 27 mm. The inner diameter of the introducer sheath 196 is set tosuch an extent that the endoscope 90 can be inserted into the sheath196. The diameter is, for example, 3 mm to 30 mm, especially preferably3 mm to 25 mm.

The introducer hand portion 198 is a hard pipe-like member formed, forexample, of a resin material, and is pressed in the introducer sheath196, and bonded, for example, by ultrasonic fusion bonding, thermalfusion bonding, and solvent adhesive, or fixed by screwing. To preventair sucked or fed in the tube main body 12 (introducer 194) from beingreleased, the same valve mechanism (not shown) as that described in thefirst embodiment is disposed in the introducer hand portion 198, andairtightness between interior and exterior of the body is maintained.

Next, a function of an over-tube 10 having this constitution will bedescribed.

The internal cover 60 is disposed in the inner cavity of the over-tube10. The endoscope 90 and the treatment device are inserted in the innercavity of the internal cover 60 beforehand. The over-tube 10 in thisstate is inserted into the lumen wall 100 (see FIGS. 7 and 8) throughthe natural opening in the patient's body. The target lumen wall 100 isopened by the endoscope 90 and the treatment device. After opening thewall, the over-tube main body 12 is fixed to the opening (lumen wall100). The endoscope 90 and the treatment device are extracted. Theinternal cover 60 in the over-tube main body 12 is extracted from thehand side of the over-tube 10.

The sterilized introducer 194 is inserted into the over-tube main body12 instead of the internal cover 60. The endoscope 90 and the treatmentdevice are inserted into the inner cavity of the introducer 194 toaccess the target part in the abdominal cavity, and an endoscopictreatment is performed.

Since other functions are similar to those described in the firstembodiment, description thereof is omitted.

As described above, according to this embodiment, the following effectis obtained. It is to be noted that the description of the effectdescribed in the first embodiment is omitted.

The introducer 194 is disposed in the inner cavity of the over-tube 10whose distal end portion is engaged with the lumen wall 100 (opening).Therefore, the endoscope 90 and the treatment device can be moresecurely protruded from the distal end portion of the over-tube 10engaged with the lumen wall 100. Then, accessibility in the abdominalcavity can be enhanced.

Since the introducer 194 has the valve mechanism, anairtight/liquid-tight state can be maintained, and permeation ofbacteria by insertion/detachment of the endoscope 90 or the treatmentdevice can be prevented.

Several embodiments have been concretely described with reference to thedrawings, but the present invention is not limited to theabove-described embodiment, and all implementations performed withoutdeparting from the scope are included.

1-41. (canceled)
 42. A method of disposing an over-tube, comprising:inserting an over-tube having an internal cover disposed in an innercavity thereof from a natural opening in a patient's body; engaging thedistal portion of the over-tube with a lumen wall; removing the internalcover from the inner cavity of the over-tube; and inserting an insertionsection of an endoscope into the inner cavity of the over-tube.
 43. Amethod of treatment in an abdominal cavity using the method of disposingthe over-tube according to claim 42, comprising: introducing a treatmentdevice further through an inner cavity of the over-tube; guiding theendoscope and the treatment device into a position to be treated;treating the position to be treated with the treatment device whileobserving the position with the endoscope; extracting the endoscope andthe treatment device from the inner cavity of the over-tube; andextracting the over-tube.
 44. A method of the treatment in the abdominalcavity according to claim 43, further comprising: cleaning the inside ofthe abdominal cavity.
 45. A method of the treatment in the abdominalcavity according to claim 44, further comprising: sucking a cleaningsolution by the cleaning in the abdominal cavity.